FDA Registration
Active
🇺🇸 United States
STERIS CORPORATION
Reg #: 1527821
·
FEI: 1527821
·
Expires 2026
Products
4
Proprietary Names
25
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- STERIS CORPORATION
- Registration Number
- 1527821
- FEI Number
- 1527821
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- ZIP
- 44060
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191343
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 10078069
- Address
- 5960 Heisley Road
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilant, Medical Devices | MED | Class 2 | General Hospital | No | 2020-10-13 |
| Sterilizer, Chemical | MLR | Class 2 | General Hospital | No | 2020-10-13 |
| Accessories, Cleaning, For Endoscope | FEB | Class 2 | Gastroenterology, Urology | No | 2023-09-14 |
| Disinfectant, Subsystem, Water Purification | NIH | Class 2 | Gastroenterology, Urology | No | 2023-01-20 |
Proprietary Names
S40 Sterilant Concentrate (MM-MF, CM-SD)
SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6800) (QB-CFE)
SYSTEM 1 endo Quick Connects (HP-MF, CM-SD)
SYSTEM 1 endo Trays and Containers (QB-MF, CM-SD)
SYSTEM 1 endo Liquid Chemical Sterilant Processing System (P6900) (QB-MF, CM-SD)
SYSTEM 1E Liquid Chemical Sterilant Processing System (QB-MF, CM-SD)
SYSTEM 1E Trays and Containers (QB-MF, CM-SD)
SYSTEM 1E Quick Connects (HP-MF, CM-SD)
V-PRO 60 Low Temperature Sterilization System (MY-CFE)
VAPROX HC Sterilant (PB007, PB011, PB012) (MM-MF, CM-SD)
V-PRO S2 Low Temperature Sterilization System (MY-MF, CM-SD)
enspire 3000 Series Cleaning and Liquid Chemical Sterilant Processing System (MM-MF, CM-SD)
enspire 3000 MaxFlow connectors (HP-MF, CM-SD)
V-PRO maX 2 Low Temperature Sterilization System (MY-MF, CM-SD)
AMSCO V-PRO 1 PLUS Low Temperature Sterilization System (MY-CFE)
AMSCO V-PRO maX Low Temperature Sterilization System (MY-CFE)
AMSCO V-PRO 1 Low Temperature Sterilization System (MY-CFE)
Amsco V-PRO 1 Low Temperature Sterilization Systems (MY-CFE)
VAPROX HC Sterilant (PB007) (MM-MF, CM-SD)
VAPROX HC Sterilant (PB011 and PB012) (MM-MF, CM-SD)
Amsco V-PRO 1 Low Temperature Sterilization System (MY-CFE)
Amsco V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE)
AMSCO V-PRO 1 Plus Low Temperature Sterilization System (MY-CFE)
Minncare HD
V-PRO maX Low Temperature Sterilization System (MY-CFE, CM-SD)
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility